WHO approves first vaccine against mpox

The World Health Organization (WHO) approved this Friday the use of the first vaccine against mpox with the aim of Facilitate greater and timely access for millions of people at risk in Africawhere the latest outbreak has infected more than 20,000 people so far this year.

The MVA-BN vaccine from the Danish pharmaceutical company Bavarian Nordic It was prequalified by the WHO on Friday and has already been approved in Europe and the United States for use in adults.

WHO approval will accelerate access for millions of people, which will help reduce transmission and contain the outbreak.

WHO Director-General Tedros Adhanom Ghebreyesus said that prequalification of the vaccine is an important step in the fight against the mpox virus in Africa.

Equal access

“Now We urgently need to increase procurement, donations and distribution “to ensure equitable access to vaccines where they are most needed, along with other public health tools, to prevent infections, stop transmission and save lives,” Tedros said.

Since the start of the global mpox outbreak in 2022, some 120 countries have confirmed more than 103,000 cases.

The WHO prequalification is based on the evaluation of information submitted by the manufacturer, also reviewed by the European Medicines Agency, the regulatory agency of record for this vaccine.

Proven effectiveness

Since the start of the global outbreak in 2022, The safety and efficacy of the vaccine has been proven in clinical studies and in the real worldin different contexts, mainly with the emergence of new strains of the virus.

The MVA-BN vaccine can be administered to people aged 18 years and older in two injectable doses four weeks apart. After prior cold storage, the vaccine can be stored at 2-8°C for up to eight weeks.

The health agency also recommends the Single dose use in outbreak situations with supply constraintsand stresses the need to collect more data on the number of doses.

WHO reviewed all available evidence and recommended the use of MVA-BN vaccine in the context of an mpox outbreak for people at high risk of exposure.

Although MVA-BN is not currently licensed for people under 18 years of age, this vaccine can be used “off-label” in infants, children and adolescents, and in pregnant and immunocompromised people. This means that the use of The vaccine is recommended in outbreak contexts where the benefits of vaccination outweigh the potential risks..

So far, the data show that administration of a single dose of the MVA-BN vaccine before exposure has an estimated efficacy of 76% in protection of people against mpox, and that the two-dose regimen achieves an estimated efficacy of 82%. Vaccination after exposure is less effective than vaccination before exposure.

Other vaccines are being evaluated

Since the WHO Director-General activated the emergency use listing for mpox vaccines on 7 August 2024, WHO has conducted programmatic and product capacity assessments.

“The findings of the assessments are particularly relevant in the context of the declaration of a public health emergency of international concern related to the worsening of mpox in Africa“explained Dr Rogerio Gaspar, Director of Regulatory and Prequalification at WHO.

Gaspar added that the health agency is advancing in the prequalification and inclusion procedures in the list of emergency use vaccines with the manufacturers of two other mpox vaccines“We have also received six expressions of interest so far for mpox diagnostic products for inclusion on the emergency use listing,” he added.

The logistics of distributing the vaccine

Once the vaccine is acquired, international organizations such as the United Nations Children’s Fund (UNICEF) and Gavi, the Vaccine Alliance, will be able to help distribute it globally, particularly to communities in Africa, such as the Democratic Republic of the Congo.

More than 120 countries have confirmed more than 103,000 cases of mpox since 2022In 2024 alone, there were 25,237 suspected and confirmed cases and 723 deaths from different outbreaks in 14 countries in Africa, according to data as of September 8, 2024.